Overweight Clinical Trial
Official title:
Is the Support of a Web-based Weight Loss Program Effective in Supporting Self-initiated Weight Loss and Lifestyle Changes?
Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this. In contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population. Therefore a web-based weight loss program may be an adequate mean for many people. Now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle. It is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.
Status | Active, not recruiting |
Enrollment | 84 |
Est. completion date | July 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age 30-65 years - body Mass Index: 27-39,9 kg/m2 - ECOG-Performance status degree 0 or 1 - basal internet skills - private internet access - signed informed consent Exclusion Criteria: - malign diseases - major organ diseases - inflammatory bowel diseases - insulin - dependent diabetes mellitus - pregnancy, breast feeding - treatment of eating disorders (e.g. bulimia, anorexia nervosa) within past 5 years - parallel participation in other weight loss programs or other trials - weight loss > 5% within past 6 month - chronic therapy with glucocorticoids - subjects treated because of psychiatric disorders (e.g. schizophrenia, bipolar disorder) in the past - subjects with expected non-compliance to protocol guidelines |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | KiloCoach e.U. | Vienna | |
Germany | Charité- Universitätsmedizin Berlin | Berlin | |
Germany | University Hospital Regensburg | Regensburg |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | KiloCoach e.U., University Hospital Regensburg |
Austria, Germany,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | body weight reduction in % | after 3 months | No | |
Secondary | body weight reduction in % | after 6 and 12 months | No | |
Secondary | cardiovascular risk | Cardiovascular risk is assessed by hsCRP, Fetuin A, LDL/HDL-ratio, waist-to-hip-ratio, HOMA-IR, blood pressure, body mass index, lean body mass (LBM), fat mass (FM), body cell mass (BCM.) | after 3,6 and 12 months | No |
Secondary | Quality of life | Quality of life is assessed by "Obesity and Weight-Loss Quality of Life-Instrument" and "Weight related symptom measure". | after 3,6 and 12 months | No |
Secondary | Nutrition and physical activity | Nutritional intake (controls) is assessed by 3-day dietary protocols. Physical activity is assessed by "International physical activity questionnaire" (IPAQ-long), lower limb strength and phase angle. | after 3,6 and 12 months | No |
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